SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY
FDA premarket approval P900067/S003 · decided 2002-01-29
Approval details
- PMA number
- P900067
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY
- Generic name
- Gases used within eye to place pressure on detached retina
- Applicant
- Airgas Therapeutics, LLC
- Date received
- 2001-12-26
- Decision date
- 2002-01-29
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Plumsteadville, PA
- Statement
- APPROVAL FOR LABELING MODIFICATIONS TO IMPROVE THE PATIENT'S AND DOCTOR'S KNOWLEDGE REGARDING THE HAZARDS OF USING NITROUS OXIDE FOR A SUBSEQUENT SURGICAL PROCEDURE WHEN GAS IS STILL PRESENT IN THE EYE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ULSPIRA TS™ Nitric Oxide Therapy System (K242374) | Airgas Therapeutics, LLC | 2025-01-17 |